AstraZeneca (LSE:AZN) said its SAFFRON Phase III trial met both primary and key secondary endpoints, with Tagrisso (osimertinib) plus Orpathys (savolitinib) showing statistically significant and clinically meaningful improvements in progression-free survival and overall survival against chemotherapy.
The trial targeted a specific resistance mechanism: patients with EGFR-mutated non-small cell lung cancer whose tumours developed high levels of MET overexpression or amplification after progressing on Tagrisso, a pattern that affects roughly one in three patients on third-generation EGFR inhibitors.
It is the first global Phase III trial to demonstrate significant PFS and OS benefits in this specific setting, according to AstraZeneca.
Susan Galbraith, the company's executive vice president of oncology haematology R&D, said the combination aims to deliver "the first biomarker-directed, all-oral option in this setting to patients across the globe."
The 338-patient trial ran across 230 centres in 29 countries, comparing the combination against platinum-based chemotherapy, with no new safety findings reported beyond the known profiles of each drug.
The Tagrisso-Orpathys combination is already approved in China for this patient population based on the earlier SACHI Phase III trial, and holds temporary authorisation in Switzerland based on the Phase II SAVANNAH study.
Orpathys is jointly developed by AstraZeneca and HUTCHMED and commercialised by AstraZeneca.
The SAFFRON data will be presented at a forthcoming medical meeting and submitted to global regulatory authorities.
News Intelligence what this means for the company
AstraZeneca's SAFFRON Phase III trial met both primary and secondary endpoints, showing Tagrisso plus Orpathys significantly extended progression-free and overall survival versus chemotherapy in EGFR-mutated lung cancer patients with MET overexpression who had progressed on Tagrisso alone—a resistance pattern affecting roughly one in three patients on third-generation EGFR inhibitors. This is the first global Phase III trial to demonstrate significant survival benefits in this specific biomarker-defined setting, and the all-oral combination is already approved in China and holds temporary authorisation in Switzerland, positioning AstraZeneca to expand a targeted oncology option across global markets.
- HUTCHMED, co-developer of Orpathys, gains validation of the combination's efficacy ahead of global regulatory submissions and potential expanded commercialisation beyond current approvals in China and Switzerland.
The trial success reinforces AstraZeneca's oncology pipeline strength at a time when the company reported first-half 2026 revenue of $30.67bn with oncology offsetting declines elsewhere. Regulatory approvals in major markets could add a biomarker-directed, all-oral option to the Tagrisso franchise, though the specific patient population (MET-driven resistance post-Tagrisso progression) is narrower than the broader EGFR-mutated lung cancer market.
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